JP7033088B2 - Disposable devices and devices for aseptically applying liquids with non-sterile reusable devices - Google Patents

Description

INDUSTRIAL APPLICABILITY According to the present invention, a disposable device for aseptically handling a non-sterile reusable device is provided. The disposable device comprises a film having a lower side and a sterile upper side and at least one adapter having a lower side and a sterile upper side, the sterile upper side of the adapter being suitable for receiving a sterile applicable device. In the apparatus of the present invention, the lower side of the adapter forms an irreversible and airtight connection with the upper side of the film, which is suitable for protection from contamination of the upper side of the film by contaminants generated on the lower side of the film. It is characterized by. Importantly, the underside of the adapter has at least one fixation point to establish a reversible and mechanical connection to the non-sterile reusable device. The device of the present invention prevents contaminants from reaching the sterile upper side of the adapter and the upper side of the film when connected to a non-sterile reusable device. Thus, contamination of the sterile applicable device connected to the device of the invention via the adapter is prevented. In addition, devices for aseptic application and methods for aseptically covering non-sterile reusable devices are presented.

Disposable sterile covers are of interest to many innovative medical devices with electrical, electromechanical and / or electronic components. Aseptic treatment of biomedical equipment, if including electrical or electronic components, is used for liquids, vapors and / or other methods (thermal effects), or for cleaning or sterilization, which are used for cleaning or sterilization. It can be a challenge because it must not be exposed to any substance. For example, it relates to the following medical devices:
a) A device intended to spray a cleaning solution for wound cleaning in a manner that protects the tissue by a spray head (eg, a sterile disposable spray head that can keep the wound moist or clean it). Non-sterile medical spray equipment with);
b) A device intended to apply a debridement solution (excision solution) for wound debridement (excision solution) to polish onto the wound with a high pressure pump (eg, for surgical spray debridement). Non-sterile pumping equipment with a sterile disposable spray head, or cutting equipment for medical split skin manufacturing with a non-sterile drive and sterile disposable cutting components); and / or
c) A spray device intended to evenly spread the solution from a medical luer lock syringe over the wound by a motor driven piston pump.

The equipment involved is typically a disposable component that must be held and operated by a user wearing sterile gloves, and a component for reuse (eg, reuse such as a key component of the device). With possible components). Reusable components include, within them, electrical, electronic, or other delicate components. As a result, their aseptic treatment carries the risk of irreversibly destroying these delicate parts.

Spraying cells is of interest for spraying cell suspensions on specific surfaces (eg, on wound tissue). Cell spraying is used, for example, to regenerate damaged tissue in surgery. Skin flap transplantation belongs to this field for the purpose of treating skin defects. In general, this type of transplant is characterized according to its recipient-donor relationship. The most frequently used transplants are "autologous" transplants, where the skin is removed from one area of the patient's body and transferred to another area of the same patient's body. The transplanted tissue inherent in the body then develops its own blood supply at the target location and is finally connected to the tissue at the transplant site. Currently, a variety of different skin grafts are used, especially within complete skin grafts and split skin grafts and mesh skin grafts. Each of these transplantation methods must be prepared using a particular technique and has its implicit advantages and disadvantages.

One method for obtaining tissue is in vitro culture of epidermal cells for a cell-based wound cover (“cell sheet”). First, suitable skin components, such as epithelial cells, determined to be self-derived are obtained from the patient, which cells are then augmented (regenerated) and prepared in vitro. The autoepithelial cell graft thus cultured is provided in a coherently grown cell complex (sheet). This development presents an important addition in the coverage of fairly large areas of skin wounds, such as burns. The advantage of this methodology lies in the ability of cells to achieve a coherent cell complex suitable as a so-called cell sheet for transplantation. Thus, this methodology avoids many of the drawbacks of the "widespread" skin graft methods described above, for example by reducing the need for donor skin. However, these cell complexes cultured in vitro grow relatively slowly, which is contrary to the desire to cover the wound in the wound area of the recipient to be treated as quickly as possible.

Alternatives describe the use of individual cells, i.e., the use of cells outside the cell complex. These cells are suspended in solution and applied to wound skin in this suspension. (See Navarra et al. (2000) J. Burn Care & Rehabilitation, 21: 513-518 and Wood et al. (2003) J. Wounds, 15: 16-22). The cell suspension can be applied in small amounts over the transplant area via pipetting or dripping, syringes or similar instruments. Electrically actuated and electronically controlled spray devices, in contrast, allow controlled application of the cells to the wound surface. The manual cell atomizer does not contain any electrical or electronic components and can be sterilized without difficulty. In contrast, automatic cell atomizers have motor drives, batteries, and similar sensitive components (eg, electric wires), which are aseptically treated by the effects of water, disinfection, and / or heat. Can be irreversibly damaged during.

In "surgical sterility technology", a steam-sterile surgical sheet is wrapped around a non-sterile part of the equipment, and the user of the device (eg, a surgeon) operates the non-sterile device through the sheet in a sterile manner. be able to. Typically, the plastic material tube is simply pressed against a piece of equipment, but the electronic part of the equipment is handled by the surgeon in a non-sterile manner, thereby making the surgeon's surgical gloves non-sterile. If the surgeon's surgical gloves are to remain sterile, the entire device must be sterile before surgery, although the above drawbacks are associated with it.

An object of the present invention is a disposable device that allows a non-sterile reusable device to be handled in a sterile manner without the need to pre-sterilize (sterilize) the non-sterile reusable device. Is to provide a method.

This object is achieved by the disposable device of claim 1 and the device for aseptic application of claim 11. Dependent claims reveal favorable progress.

INDUSTRIAL APPLICABILITY According to the present invention, a disposable device for aseptically handling a non-sterile reusable device is provided, and the disposable device is a disposable device.
a) A film with a lower side and a sterile upper side; and
b) The sterile upper side of the adapter is suitable for receiving a sterile applicable device, with at least one adapter having a lower side and a sterile upper side;
The underside of the adapter forms an irreversible and airtight connection (13) with the top (7) of the film (3), and the underside (12) of the adapter (4) is sterile and reusable. It is characterized by having at least one fixation point for establishing a reversible and mechanical connection to the device.

Disposable devices can be reversibly connected to non-sterile reusable devices by adapters. When connecting the two types of devices, the non-sterile reusable device is protected by a disposable device. It is desirable that contaminants (microorganisms and viruses) cannot reach the sterile upper side of the film and the sterile upper side of the adapter. Potential contamination of the sterile upper side of the adapter and the sterile applicable device connected to it is thus prevented. The reusable device as the "main device" may remain non-sterile and by the use of the disposable device according to the invention, even without prior sterilization (sterilization), surgery. It can be used in a sterile manner in the room. Therefore, aseptic treatment of the "main equipment" is no longer necessary.

Using disposable equipment as a cover for "main equipment" instead of "main equipment" sterilization is more time efficient, does not consume energy or chemicals for sterilization, and is often expensive reuse. Avoid possible damage to equipment. As a result, the disposable device of the present invention is more economical and environmentally friendly than sterile treatment. The sterile film of the disposable device of the present invention preferably allows the operator to grip and / or manipulate non-sterile items located underneath the film. In this regard, it is beneficial if the film is a flexible film. It is also beneficial if the film is at least partially transparent to visible light.

In the disposable device according to the present invention, the adapter is a mount for a sterile applicable device, preferably a spray head mount, a cutting head mount, a syringe mount, and / or a spray liquid container mount, more preferably a surgical spray fat. Equipped with or consisting of a spray head mount for Reedman equipment, a cutting head mount for surgical dermatomes, a syringe mount for disposable syringes, and / or a spray liquid container for surgical cell spray equipment. , May be a feature.

The film of the disposable device may have a flat or tubular structure. Optionally, it has a tubular structure and is closed on one side of the tube, preferably on the front side of the tube. In a flat structure, it is preferred that the film has a length and width corresponding to at least twice the height of the non-sterile reusable device to which it is connected (and covered). In the tubular structure, the film has a length and width suitable for completely enclosing the non-sterile reusable device to which it is connected (and covered).

In a preferred embodiment, the film is on the upper side and / or the lower side, at least in certain areas.
a) Self-adhesive (ie, having an adhesive surface); and / or
b) Equipped with sticky substances; and / or
c) Folded, preferably fan-shaped,
Has a surface.

Particularly preferably, the self-adhesive surface and / or the surface with the adhesive substance and / or the folded surface described above is placed or located at at least one end of the film. This ensures that the non-sterile reusable device is sterile on film without further closing means (eg, rubber bands, etc.) and without adhesive interaction with the non-sterile reusable device. Allows closure in an easy way. As a result of the closure, the contaminants can no longer pass through the disposable device from the non-sterile reusable device, i.e. the non-sterile reusable device is closed in a sealed state against the contaminants. Ru.

The film of the disposable device may have at least one marking point pointing to a component of the non-sterile reusable device to which it is connected. With the help of marking points, it is not necessary to check the correct orientation of the disposable device adapter, which simplifies the mounting of the disposable device on a non-sterile, reusable device.

The adapter of the disposable device may be connected to the film via adhesive and / or welded joints. It is important that the connection is made in such a way that contaminants (microorganisms and viruses) cannot pass through the junction between the adapter and the film.

At least one fixing point of the adapter may project from the top of the film to the bottom of the film through the film. In this embodiment, the film has an opening. Therefore, despite this opening, it is important that the junction between the film and the adapter is sealed against contaminants. For example, this may be guaranteed by adhesive connections and / or welded joints.

In a preferred embodiment, the fixed point comprises at least one electrical terminal that allows telecommunications with the sterile application device of the non-sterile reusable device. The advantage here is that machine communication between the reusable device and the applicable device (eg, transfer of force from the reusable device (slide) to the applicable device (syringe plunger)) is possible. Not only can the electrical application device be directly controlled (eg, control of the application device's cutting head via a rotary switch in a reusable device).

The film is
a) Length of 1 cm-500 cm, preferably 10 cm-200 cm, more preferably 20 cm-100 cm, even more preferably 40 cm-80 cm; and / or
b) 1 cm-500 cm, preferably 10 cm-200 cm, more preferably 20 cm-100 cm, even more preferably 40 cm-80 cm wide; and / or
c) A thickness of 0.01-2 mm, preferably 0.02 mm-1 mm, more preferably 0.05 mm-0.8 mm, even more preferably 0.1-0.5 mm.
May have.

The advantage of large length and width (ie, large surface expansion) is that even large non-sterile reusable devices can be covered in a sterile manner. The advantage of having a thin thickness is that the operating elements (eg, buttons and / or controllers) of the reusable device covered by the disposable device can be easily viewed and operated by the operator. In addition, the thin thickness provides that the disposable device can be manufactured at the lowest material cost, proving that the volume and weight of the disposable device is small.

The film may contain or consist of polyurethane, polyacrylate, polyvinyl chloride, polyethylene, polylactide, cellulose acetate, and / or silicone. Polyethylene, polyvinyl chloride, and mixtures thereof are particularly preferred as they have self-adhesive properties. That is, the film can be closed in a manner sealed against contaminants after covering a non-sterile reusable device without additional closing means.

Further, according to the present invention, a device for aseptic application is provided, wherein the device is:
a) Disposable device according to the present invention;
b) Aseptic applicable device;
c) Non-sterile reusable equipment including an electrical control unit to control sterile applicable devices;
Equipped with or consisting of only
The upper side of the adapter is connected to the sterile applicable device, and the lower side of the adapter is connected to the non-sterile reusable device via at least one fixing point of the adapter.
It is characterized by that.

The sterile application device may comprise a liquid, preferably a liquid containing cells, more preferably a liquid containing skin cells, and even more preferably a liquid containing self-implanted skin cells.

Electrical control of non-sterile reusable equipment is suitable for controlling the application of liquids by sterile application devices. In such devices, liquids and substances dissolved or suspended therein can be automatically applied via electrical control onto surfaces such as human or animal skin, for example.

The film may enclose the space occupied by the non-sterile reusable device, at least in part, preferably completely. It is understood that completely enclosing the space occupied by the non-sterile reusable device means that the non-sterile reusable device is completely enclosed (encapsulated) by the film.

Preferably, the disposable device of the device is
a) Through the self-adhesive surface of the film, through the adhesive material on the surface of the film and / or through folds, preferably through fan-shaped folds; and / or.
b) Via a tension band, preferably a rubber band, a plastic band, and / or an adhesive band;
Form a seal to avoid contamination of sterile applicable devices, sealed against non-sterile reusable equipment.

Sterile applicable devices include spray heads, cutting heads, syringes and / or spray containers, preferably spray heads for surgical spray debreedman equipment, cutting heads for surgical dermatomes, disposable syringes, and / or. , Equipped with, or only a spray container for surgical cell spray equipment.

In a preferred embodiment, the non-sterile reusable device comprises at least one fixation point for connecting (and preferably fixing) to a sterile application device (preferably a slide), the at least one fixation point. Suitable for transmitting mechanical forces to sterile application devices, preferably controlled by an electrical control unit.

In a more preferred embodiment, the non-sterile reusable device comprises at least one fixation point suitable for establishing a locking connection to at least one fixation point of the adapter.

The present invention further provides a method of aseptically covering a non-sterile reusable device, wherein the method is:
a) Disposable according to the invention so that the underside of the film is directed towards the non-sterile reusable device and the space occupied by the non-sterile reusable device is completely surrounded by the film. Rotate the film of the device across a non-sterile, reusable device;
b) The adapter of the disposable device is mechanically connected to the non-sterile reusable device via at least one fixing point of the adapter;
c) Airtightly close the film of the disposable device,
Have steps.

In the case of the method according to the present invention, step a) may be performed before step b), or step b) may be performed before step a).

The subject matter of the present invention will be described in more detail with reference to the following drawings and examples, but the subject matter is not limited to the particular embodiments shown herein.

FIG. 1 shows a part of the disposable device of the present invention. FIG. 2 shows the disposable device of the present invention. FIG. 3 shows a non-sterile reusable device. FIG. 4 shows a device of the invention for sterile application. FIG. 5 shows a device of the invention for sterile application. FIG. 6 shows a device of the invention for sterile application. FIG. 7 shows a device of the invention for sterile application. FIG. 8 shows a device of the invention for sterile application.

FIG. 1 shows a portion of the disposable device of the invention, i.e., an adapter 4 suitable for receiving a sterile applicable device. In this embodiment, the adapter 4 comprises a mount 5 and is therefore suitable for receiving a sterile applicable device.

FIG. 2 shows a diagram of the disposable device of the present invention. The disposable device of the present invention comprises a film 3 having a lower side 8 and a sterile upper side 7. The adapter 4 is suitable for receiving a sterile application device by connecting the sterile application device to the mount 5.

FIG. 3 shows a diagram of a non-sterile reusable device 2, where the disposable device of the present invention can establish a reversible and mechanical connection to a non-sterile reusable device. In this embodiment, the non-sterile reusable device 2 is equipped with a slide 14 suitable for applying mechanical force to the sterile applicable device received by the disposable device of the present invention. The non-sterile reusable device 2 comprises an electrical control unit 6 for controlling a sterile applicable device.

FIG. 4 shows a diagram of the device of the invention for sterile application. The disposable device of the present invention forms a reversible mechanical connection with the non-sterile reusable device 2 via its adapter 4, and the mount 5 of the disposable device of the present invention is a sterile applicable device. Receive 1 (here, a syringe). The non-sterile reusable device 2 is equipped with a slide 14 suitable for applying mechanical force to the sterile application device 1 and an electrical control unit 6 for controlling the sterile application device 1. The film, which is an essential part of the disposable device of the present invention, is omitted in this figure for clarity.

FIG. 5 shows a side view of the device of the invention for sterile application. The disposable device of the present invention is connected to a non-sterile reusable device 2 (the non-sterile reusable device 2 is indicated by a broken line) and is configured to receive a sterile applicable device 1. The non-sterile reusable device 2 is equipped with a slide 14 suitable for applying mechanical force to the sterile application device 1 and includes an electrical control unit 6 for controlling the sterile application device 1. Be prepared. The disposable device of the present invention comprises a film 3 having a lower side 8 and a sterile upper side 7. Further, the disposable device comprises at least one adapter 4 having a lower side and a sterile upper side, the sterile upper side of the adapter 4 having a mount 5 suitable for receiving the sterile applicable device 1. The underside of the adapter 4 forms an irreversible and airtight connection with the top 7 of the film 3 to protect it from contamination, i.e., the junction between the film 3 and the adapter 4 is a contamination barrier.

FIG. 6 shows a front view of the device of the invention for sterile application. The disposable device of the present invention is configured to be connected to a non-sterile reusable device 2 and receive a sterile applicable device 1. The disposable device comprises a film 3 having a lower side 8 and a sterile upper side 7. Further, the disposable device comprises at least one adapter 4 having a lower side 12 and a sterile upper side 11, the sterile upper side 11 of the adapter 4 having a mount 5 suitable for receiving the sterile applicable device 1. The lower 12 of the adapter 4 forms an irreversible and airtight connection 13 with the upper 7 of the film 3 to protect it from contamination, i.e., the junction between the film 3 and the adapter 4 is a contamination barrier. .. Further, the disposable device is characterized in that the lower 12 of the adapter 4 has at least one fixed point 9 for a reversible and mechanical connection to the fixed point 16 of the non-sterile reusable device 2. do.

FIG. 7 shows a diagram of a device of the invention for sterile application, comprising a disposable device according to the invention and a non-sterile reusable device 2. The non-sterile reusable device 2 comprises an electrical control unit 6 for controlling the sterile applicable device 1. The upper mount 5 of the adapter 4 is configured to be connected to a sterile applicable device 1 (here, a syringe), and the lower side of the adapter 4 is non-sterile via at least one fixation point on the adapter 4. Connected to the reusable device 2 of.

FIG. 8 shows a diagram of a device of the invention for sterile application, wherein the device is connected to a sterile applicable device 1 (here, a syringe) and a non-sterile reusable device 2. Provided with the disposable device of the invention. The non-sterile reusable device 2 is equipped with a slide 14 suitable for applying mechanical force to the sterile applicable device 1 and includes an electrical control unit 6 for controlling the sterile applicable device 1. Provided, it is connected to the underside of the adapter 4 via at least one fixing point of the adapter 4. The film 3 of the disposable device according to the present invention completely surrounds the sterile reusable device 2, and the enclosed space acts on the film 3 in a shrinking manner with a tension band 10 (eg, a rubber band or adhesive). It is closed in a way that is airtight to the surroundings through the band). The airtight closure via the tension band 10 avoids contamination of the sterile application device 1 by the non-sterile application device 2. In addition to, or in place of, the tension band, the lower 8 of the film 3 is on at least one edge 15 of the film 3, or next to the edge 15, a self-adhesive surface, adhesive material, and. / Or may be provided with a fan-shaped fold.

Example-Use of the disposable device according to the present invention

As an example, the aseptically packaged disposable device according to the present invention is passed from a "non-sterile" assistant to a "sterile" user (eg, a surgeon) in an operating room. The sterile packaging is then opened by the "sterile" user and the disposable device is transported to a sterile operating table. The "non-sterile" assistant then presents the "sterile" user with a non-sterile reusable device (eg, an electrically actuated cleaning nebulizer). Aseptic users are aseptic of the disposable device of the invention (optionally via an adapter) so that at least a portion, preferably all parts of the sterile application device, is protected by the film of the disposable device in a sterile manner. (Already connected to the applicable device) is turned across a non-sterile reusable device. The thinness of the film then allows the user to operate the sterile applicable device of the invention, as well as the operating elements on the reusable device (eg, on the reusable device through the film). Operation of the motor switch). In this way, the non-sterile reusable device (eg, wash atomizer) can be operated by the user in a sterile manner.

Claims (18)

A disposable device for aseptically handling a non-sterile reusable device (2).
a) A film (3) with a lower side (8) and a sterile upper side (7); and
b) The sterile upper side (11) of the adapter (4) comprises a sterile applicable device (1), comprising at least one adapter (4) having a lower side (12) and a sterile upper side (11). Suitable for receiving, said lower side (12) of said adapter (4) is at least one fixation to establish a reversible and mechanical connection to a non-sterile reusable device (2). Has point (9);
In a device in which the lower side (12) of the adapter (4) forms an irreversible and airtight connection (13) with the upper side (7) of the film (3).
The adapter comprises or consists of a mount (5) for a sterile applicable device (1), wherein the mount (5) is a syringe mount and / or a spray liquid container mount.
A disposable device characterized by that. The mount (5) is a syringe mount for a disposable syringe and / or a spray liquid container mount for a surgical cell spray device.
The disposable device according to claim 1. The film (3) has a flat structure or a tubular structure.
The disposable device according to claim 1 or 2, wherein the disposable device is characterized in that. The film (3) is on the upper side (7) and / or the lower side (8), at least in a certain region.
a) Self-adhesive; and / or
b) Equipped with sticky substances; and / or
c) Folded;
Has a surface and
A self-adhesive surface, a surface with an adhesive substance, and / or a folded surface are arranged at at least one end (15) of the film (3) or next to the end (15). ing,
The disposable device according to any one of claims 1 to 3, wherein the disposable device is characterized by the above. The film (3) has at least one marking point pointing to a component of the non-sterile reusable device (2) to be connected.
The disposable device according to any one of claims 1 to 4, wherein the disposable device is characterized by the above. The adapter (4) is connected to the film (3) via an adhesive connection (13) and / or a welded joint (13).
The disposable device according to any one of claims 1 to 5, wherein the disposable device is characterized in that. The at least one fixing point (9) of the adapter (4) passes through the film (3) from the upper side (7) of the film (3) to the lower side (8) of the film (3). Protruding,
The disposable device according to any one of claims 1 to 6, wherein the disposable device is characterized in that. The fixed point (9) comprises at least one electrical terminal that allows telecommunications of the sterile reusable device (2) with the sterile applicable device (1).
The disposable device according to any one of claims 1 to 7, wherein the disposable device is characterized by the above. The film (3) is
a) Length of 1 cm-500 cm;
b) 1 cm-500 cm width; and / or
c) 0.01mm-2mm thickness,
Have,
The disposable device according to any one of claims 1 to 8, wherein the disposable device is characterized in that. The film (3) is
Polyurethane, polyacrylate, polyvinyl chloride, polyethylene, polylactide, cellulose acetate, and / or silicone,
Containing or consisting of only
The disposable device according to any one of claims 1 to 9, wherein the disposable device is characterized by the above. A device for aseptic application,
a) The disposable device according to any one of claims 1 to 10.
b) Aseptic applicable device (1);
c) A non-sterile reusable device (2) including an electrical control unit (6) for controlling the sterile applicable device (1);
Equipped with or consisting of only
The upper side (11) of the adapter (4) is connected to the sterile applicable device (1), and the lower side (12) of the adapter (4) is at least one of the adapter (4). It is connected to the non-sterile reusable device (2) via two fixing points (9).
A device that features that. The sterile applicable device (1) comprises a liquid.
11. The device of claim 11. The electrical control unit (6) of the non-sterile reusable device (2) is suitable for controlling the application of liquid by the sterile applicable device (1).
11. The device of claim 11 or 12. The film (3) at least partially encloses the space occupied by the non-sterile reusable device (2).
The device according to any one of claims 11 to 13, wherein the device is characterized in that. The disposable device is
a) Through the self-adhesive surface of the film (3), through the adhesive material on the surface of the film (3), and / or through folds; and / or.
b) Through the tension band (10);
Forming a closure to avoid contamination of the sterile applicable device (1), sealed against the non-sterile reusable device (2).
The device according to any one of claims 11 to 14, wherein the device is characterized in that. The sterile applicable device (1) is
Equipped with or consisting of a syringe and / or a spray liquid container,
The device according to any one of claims 11 to 15, characterized in that. The non-sterile reusable device (2) comprises at least one fixation point (14) for the sterile application device (1), wherein the at least one fixation point (14) is mechanical. Suitable for transmitting force to the sterile applicable device (1),
The device according to any one of claims 11 to 16, wherein the device is characterized in that. The non-sterile reusable device (2) comprises at least one fixed point (16) suitable for establishing a lock connection to at least one fixed point (9) of the adapter (4).
The device according to any one of claims 11 to 17, wherein the device is characterized in that.

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